IVD Product Development • > 20 years of assay development experience • Biomarker assays / software development under full ISO 13485 design controls • Complementary MRD assays for all biomarkers – potential for surrogate endpoints per agency inputs, saving years in clinical trials • Comprehensive NGS gene panels that identify actionable biomarkers • Custom assays developed based on client PRD • Efficient phase completion to reduce timelines Manufacturing • FDA/CDRH-registered and ISO 13485 certified cGMP manufacturing facility • CDx Tests for multiple drugs & pharmaceutical partners • > 50 CE-IVDs • RUO assays • ASRs & GPRs • DNA / RNA controls and proficiency panels • Proven record of successful pharmaceutical and cancer center partnerships, approvals, and commercialization Clinical Testing Global Clinical Reference Laboratory Network • Harmonized testing through standardization • Over 18,000 patient samples tested per year • Testing to support drug development and clinical trials • Extensive NGS experience and freedom to operate on Illumina MiSeq® and Thermo Fisher Ion PGMTM platforms • Performing comprehensive NGS-based CAP and CLIA- certified gene panels, MyMRD® and MyAML® (23 and 194 genes, respectively) • Globally standardized FLT3 ITD and NPM1 MRD testing Quality/Regulatory/Commercialization Global Regulatory Expertise • CDx Approvals by the FDA in the US, and PMDA in Japan • Experienced staff and a proven quality system • Full adherence to FDA 21 CFR part 820 and ISO 13485 standards • Successful inspections by the FDA and ISO agencies • EN ISO 13485:2016 certified • Marketing Authorization Holder (MAH) for our products in Japan • Submissions for both PRP and reimbursement in US and Japan • Supporting ongoing clinical drug trials in the US, EU, Japan, China, and ROW An Ideal CDx Partner for Drug Approvals Partner with Us LabPMM Services Catalog 2019 | 5 Your Ideal Partner for Laboratory Services, Clinical Trial Testing, and Companion Diagnostic Development LabPMM (an Invivoscribe® company) is your partner of choice for diagnostic, research, and clinical trial services. Our network of laboratories located in the USA, Europe and Asia specialize in internationally harmonized molecular testing, and collectively have CLIA, CAP, and ISO 15189 certifications. We also offer contract research organization (CRO) services, and are a comprehensive companion diagnostics (CDx) partner, providing ISO 13485 compliant biomarker development, cGMP manufacturing, regulatory capability, global laboratory services and commercialization. We offer an ever expanding menu of molecular assays, including NGS gene and MRD panels, FLT3 and NPM1 mutation assays, B- and T-cell clonality and MRD assessment. These services allow for a better understanding of the patients’ genetic landscape and can help accelerate drug approval. State-of-the-Art We thrive in international cooperation and in continuously investing in the advancement of precision medicine. We work with a full range of collaborators: key opinion leaders; leading healthcare institutions; top-tier pharmaceutical companies; and, importantly, we work on the premise that all those reliant on data and results from clinical testing - healthcare providers, pharmaceutical companies and, most importantly, patients - will benefit from better standardization and more consistent performance of molecular diagnostic tests. Partner with Us Contact us for more information: businessdevelopment@invivoscribe.com Quality Internationally harmonized diagnostics through our global network of laboratories. We follow full QSR design control for assay and software development. Products are manufactured under cGMP and ISO 13485. Partnership We support partnerships worldwide to develop, validate, and commercialize molecular assays and reagents. Our global distribution network operates in more than 700 laboratories in over 100 countries. Expertise With over 20 years of experience we are the foremost experts in providing molecular products and services for leukemia and lymphoma testing. We offer dedicated support in design and development, manufacturing, software and bioinformatics, technical support, quality asurance, and global regulatory affairs. 4